Transcatheter Valve-in-Valve Implantation Using CoreValve Revalving System for Failed Surgical Aortic Bioprostheses Francesco Bedogni, Maria Luisa Laudisa, Samuele Pizzocri, Corrado Tamburino, Gian ...Paolo Ussia, Anna Sonia Petronio, Massimo Napodano, Angelo Ramondo, Patrizia Presbitero, Federica Ettori, Gennaro Santoro, Silvio Klugman, Federico De Marco, Nedy Brambilla, Luca Testa CoreValve Revalving System (Medtronic, Minneapolis, Minnesota) implantation could be a valid option for patients with a failed aortic bioprosthesis deemed at prohibitive risk for surgical redo. In this multicenter consecutive cohort of 25 patients, the CoreValve Revalving System was feasible and effective regardless of the prevalent cause of failure (regurgitation or stenosis), with excellent procedural success and a considerable 6-month survival rate. These results can significantly affect the treatment of such a high-risk population.
Although transcatheter aortic valve implantation (TAVI) is still currently guided by transesophageal echocardiography (TEE) in a considerable number of hospitals, exclusive angiographic (Angio) ...guidance seems a reasonable approach in this setting. To date, however, no studies have directly compared the outcomes of TAVI according to the imaging modality used for procedural guidance. We, therefore, used data from a large multicenter data repository to compare the outcomes of TAVI guided exclusively by Angio and ATEE. All consecutive patients with severe aortic stenosis who underwent TAVI with the CoreValve Revalving System (CRS) in 9 Italian centers from September 2007 to March 2014, dichotomized according to the imaging support used to guide the procedure (ATEE and Angio), were included. Thirty-day and 12-month clinical outcomes were evaluated. Propensity matching analysis was performed to adjust for baseline differences. A total of 625 patients were included (256 and 369 patients were included in the ATEE and Angio groups, respectively). Patients from the ATEE more frequently underwent TAVI under general anesthesia compared with Angio group (37.9% vs 22.8%, respectively, p <0.001). Importantly, ∼80% of the patients experienced mild or even less aortic regurgitation as assessed by angiography after the procedure, without between-group differences. Postdilation and valve-in-valve rates were equivalent (24.7% vs 25%, p = 0.934 and 5.5% vs 3.4%, respectively, p = 0.217). No differences were revealed in the rates of death, cardiovascular death, and stroke or transient ischemic attack at 12-month follow-up. These results were sustained after propensity matching analysis. In conclusion, as long as a comprehensive procedural planning is performed, TAVI with CRS may be performed exclusively under angiographic guidance without the need for associated TEE.
The causes of death within 1 year of hospital admission in patients with non–ST-segment elevation acute coronary syndromes are ill defined, particularly in patients aged ≥75 years. From January 2008 ...through May 2010, we enrolled 645 patients aged ≥75 years with non–ST-segment elevation acute coronary syndromes: 313 in a randomized trial comparing an early aggressive versus an initially conservative approach, and 332, excluded from the trial for specific reasons, in a parallel registry. Each death occurring during 1 year of follow-up was adjudicated by an independent committee. The mean age was 82 years in both study cohorts, and 53% were men. By the end of the follow-up period (median 369 days, interquartile range 345 to 391), 120 patients (18.6%) had died. The mortality was significantly greater in the registry (23.8% vs 13.1%, p = 0.001). The deaths were classified as cardiac in 94% of the cases during the index admission and 68% of the cases during the follow-up period. Eighty-six percent of the cardiac deaths were of ischemic origin. In a multivariate logistic regression model that included the variables present on admission in the whole study population, the ejection fraction (hazard ratio 0.95, 95% confidence interval 0.94 to 0.97; p <0.001), hemoglobin level (hazard ratio 0.85, 95% confidence interval 0.76 to 0.94; p = 0.001), older age (hazard ratio 1.05, 95% confidence interval 1.01 to 1.10, p = 0.010), and creatinine clearance (hazard ratio 0.99, 95% confidence interval 0.97 to 0.99; p = 0.030) were the independent predictors of all-cause death at 1 year. In conclusion, within 1 year after admission for non–ST-segment elevation acute coronary syndromes, most deaths in patients aged ≥75 years have a cardiac origin, mostly owing to myocardial ischemia.
Approximately 1/3 of patients with non–ST-segment elevation (NSTE) acute coronary syndromes (ACS) are ≥75 years of age. Risk stratification in these patients is generally difficult because supporting ...evidence is scarce. The investigators developed and validated a simple risk prediction score for 1-year mortality in patients ≥75 years of age presenting with NSTE ACS. The derivation cohort was the Italian Elderly ACS trial, which included 313 patients with NSTE ACS aged ≥75 years. A logistic regression model was developed to predict 1-year mortality. The validation cohort was a registry cohort of 332 patients with NSTE ACS meeting the same inclusion criteria as for the Italian Elderly ACS trial but excluded from the trial for any reason. The risk score included 5 statistically significant covariates: previous vascular event, hemoglobin level, estimated glomerular filtration rate, ischemic electrocardiographic changes, and elevated troponin level. The model allowed a maximum score of 6. The score demonstrated a good discriminating power (C statistic = 0.739) and calibration, even among subgroups defined by gender and age. When validated in the registry cohort, the scoring system confirmed a strong association with the risk for all-cause death. Moreover, a score ≥3 (the highest baseline risk group) identified a subset of patients with NSTE ACS most likely to benefit from an invasive approach. In conclusion, the risk for 1-year mortality in patients ≥75 years of age with NSTE ACS is substantial and can be predicted through a score that can be easily derived at the bedside at hospital presentation. The score may help in guiding treatment strategy.
The aim of this study was to investigate the effects of transcatheter aortic valve implantation (TAVI) on left ventricular (LV) hypertrophy and diastolic function in patients with severe aortic valve ...stenosis (AVS). There are few and conflicting data on LV mass remodeling and LV diastolic function after TAVI.
Echocardiography and clinical assessment were performed at baseline and at 6 months in high-risk patients affected by severe AVS who underwent TAVI.
One hundred thirty-five patients successfully underwent TAVI. Peak transvalvular aortic pressure gradient and mean transvalvular aortic pressure gradient were reduced from 87 ± 25 to 18 ± 7 mm Hg and from 54 ± 14 to 9 ± 4 mm Hg, respectively (P < .001), accompanied by significant clinical improvement. The mean LV ejection fraction improved from 50 ± 13% to 54 ± 11% during follow-up (P = .009). At 6-month follow-up, interventricular septal wall thickness regressed from 14 ± 2 to 12 ± 1 mm and posterior wall thickness from 13 ± 3 to 11 ± 2 mm (P < .001). LV mass and LV mass index decreased from 332 ± 106 to 228 ± 58 g (P < .001) and from 191 ± 58 to 132 ± 30 g/m(2) (P < .001), respectively. Ninety-seven patients (72%) showed improvements in LV diastolic filling pattern. The mean e' value increased from 4.1 ± 1.7 to 5.6 ± 2.2 cm/sec, and the mean E/e' ratio decreased from 24 ± 7 to 17 ± 6 (P < .001) after TAVI.
Significant LV mass reverse remodeling associated with improvement in LV systolic and diastolic function was found in patients with severe AVS 6 months after TAVI. These changes may have relevant clinical prognostic value.
Reciprocal ST-segment downsloping on electrocardiogram is a frequent finding during ST-elevated myocardial infarction (STEMI), but its etiology is still disputed. We sought to evaluate the relation ...between reciprocal ST-segment downsloping during STEMI and major cardiac perfusion and functional parameters. One hundred eighty-five patients with STEMI underwent emergency coronary angiography. The presence of reciprocal ST-segment downsloping was assessed. At coronary angiography, the corrected TIMI frame count (cTFC) was computed both on culprit and remote vessels and the occurrence of “no/slow reflow” phenomenon after percutaneous coronary intervention (PCI) identified. The left ventricular wall motion score index ratio (discharge/admission values) at echocardiography and the slope of high-sensitivity troponin elimination were computed as measures of effective myocardial reperfusion. Reciprocal ST-segment downsloping was revealed in 91 patients (49%). They presented higher cTFC values on remote vessels than patients without reciprocal electrocardiographic abnormalities (44 ± 18 vs 37 ± 15 cineframes × second−1 , p = 0.004). The presence of remote ST-segment downsloping was also associated with a higher prevalence of “no/slow reflow” phenomenon (59% vs 40%, p = 0.013) as well as more abnormal values of wall motion score index ratio (p = 0.042) and high-sensitivity troponin slope (p = 0.012). At multivariate analyses, a higher cTFC on remote vessels predicted the occurrence of reciprocal ST-segment changes (p = 0.018) and the development of “no/slow reflow” phenomenon after PCI (p = 0.005). In conclusion, the presence of reciprocal ST-segment downsloping during STEMI clusters with significant perfusion and cardiac functional abnormalities, predicting the development of “no reflow” phenomenon after PCI.
Abstract Objectives The aim of this study was to evaluate the use of transcatheter heart valves (THV) for the treatment of noncalcific pure native aortic valve regurgitation (NAVR) and failing ...bioprosthetic surgical heart valves (SHVs) with pure severe aortic regurgitation (AR). Background Limited data are available about the “off-label” use of transcatheter aortic valve replacement (TAVR) to treat pure severe AR. Methods The study population consisted of patients with pure severe AR treated by TAVR at 18 different centers. Study endpoints were device success, early safety, and clinical efficacy at 30 days, as defined by Valve Academic Research Consortium 2 criteria. Results A total of 146 patients were included, 78 patients in the NAVR group and 68 patients in the failing SHV group. In the NAVR group, device success, early safety, and clinical efficacy were 72%, 66%, and 61%, respectively. Device success and clinical efficacy were significantly better with newer generation THVs compared with old-generation THVs (85% vs. 54% and 75% vs. 46%, respectively, p < 0.05); this was mainly due to less second THV implantations and a lower rate of moderate to severe paravalvular regurgitation (10% vs. 24% and 3% vs. 27%, respectively). Independent predictors of 30-day mortality were body mass index <20 kg/m2 , STS surgical risk score >8%, major vascular or access complication, and moderate to severe AR. In the failing SHV group, device success, early safety, and clinical efficacy were 71%, 90%, and 77%, respectively. Conclusions TAVR for pure NAVR remains a challenging condition, with old-generation THVs being associated with THV embolization and migration and significant paravalvular regurgitation. Newer generation THVs show more promising outcomes. For those patients with severe AR due to failing SHVs, TAVR is a valuable therapeutic option.
Background Drug-eluting stents (DESs) introduction has somewhat renewed the issues of strategy and stenting technique for treatment of bifurcation lesions. In particular, concerns remain on extensive ...use of DESs, especially in the side branch, and on time of dual antiplatelet therapy (DAT) discontinuation, reflecting lack of pertinent long-term data. This study aimed to evaluate clinical safety and efficacy of different strategies for bifurcations treatment in a large observational real-world registry. Methods A multicenter, retrospective Italian study of consecutive patients undergoing bifurcation percutaneous coronary intervention between January 2002 and December 2006 was performed. The primary end point was the long-term rate of major adverse cardiac events (MACEs). The role of DAT length on outcome was also analyzed. Results A total of 4,314 patients (4,487 lesions) were enrolled at 22 independent centers. In-hospital procedural success rate was 98.7%. After median follow-up of 24 months, MACEs occurred in 17.7%, with cardiac death in 3.4%, myocardial infarction in 4.0%, target lesion revascularization in 13.2%, and stent thrombosis in 2.9%. Extensive multivariable analysis showed that MACEs were independently predicted by age, diabetes, renal failure, systolic dysfunction, multivessel disease, myocardial infarction at admission, restenotic lesion, bare-metal stent implantation, complex stenting strategy, and short duration of DAT. Conclusions This large study based on current clinical practice in an unselected patient population presenting with bifurcation disease and submitted to percutaneous coronary intervention demonstrated favorable long-term clinical results in this challenging patient setting, especially when DESs, simple stenting strategy, and DAT for at least 6 months are used.
Background The optimal antiplatelet regimen in elective patients undergoing complex percutaneous coronary interventions (PCIs) is uncertain. We aimed to assess the impact of glycoprotein IIb/IIIa ...(GpIIb/IIIa) inhibition with eptifibatide in clinically stable subjects with diffuse coronary lesions. Methods Patients with stable coronary artery disease undergoing PCI by means of implantation of >33 mm of drug-eluting stent were single-blindedly randomized to heparin plus eptifibatide versus heparin alone. The primary end point was the rate of abnormal post-PCI creatine kinase–MB mass values. Secondary end points were major adverse cardiovascular events (MACEs) (ie, cardiac death, myocardial infarction, or urgent revascularization) and MACE plus bailout GpIIb/IIIa inhibitor use. Results The study was stopped for slow enrollment and funding issues after including a total of 91 patients: 44 were randomized to heparin plus eptifibatide, and 47, to heparin alone. Analysis for the primary end point showed a trend toward lower rates of abnormal post-PCI creatine kinase–MB mass values in the heparin-plus-eptifibatide group (18 41%) versus the heparin-alone group (26 55%, relative risk 0.74 95% CI 0.48-1.15, P = .169). Similar nonstatistically significant trends were found for rates of MACE, their components, or MACE plus bailout GpIIb/IIIa inhibitors (all P > .05). Notably, heparin plus eptifibatide proved remarkably safe because major bleedings or minor bleeding was uncommon and nonsignificantly different in both groups (all P > .05). Conclusions Given its lack of statistical power, the INSTANT study cannot definitively provide evidence against or in favor of routine eptifibatide administration in stable patients undergoing implantation of multiple drug-eluting stent for diffuse coronary disease. However, the favorable trend evident for the primary end point warrants further larger randomized studies.
Reoperation was reported in 2 cases: a 60-year-old woman with severely impaired left ventricular function underwent cardiac transplantation and concomitant CV prosthesis removal, and a 30-year-old ...man with pre-existing mitral prosthesis dysfunction and residual moderate or severe perivalvular leak after TAVI underwent combined surgical aortic and mitral replacement with mechanical prostheses 2 months after TAVI, after the clinical and hemodynamic conditions improved, to allow a surgical approach. ...a minimum significant reduction in mean systolic pulmonary arterial pressure was reported (from 49.5 ± 15.6 mm Hg to 43.4 ± 10.2 mm Hg, p = 0.032).
PDF
